Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

innovation, community, workplace culture, collaboration-GettyImages-2224119114

Wasted Words: Improving Content At Conferences

In-person events should be a tool for separating the noise from authentic signals. Through “content design,” the best conferences provide you direct market insights via information aggregation, discussion, and business meetings. The founders of CDMO Live conferences speak with Chief Editor Louis Garguilo on “curating" events for optimal development and manufacturing outsourcing outcomes. In short: No wasted words; no wasted time.

GUEST COLUMNISTS

FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

PHARMA OUTSOURCING WHITE PAPERS

Early-Phase Injectable Formulation Development
Discover how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

Bioconjugates – An Increasing Diversity, A Blossoming Of Therapeutic Applications
Harness the power of bioconjugation to revolutionize targeted therapies, enhance drug efficacy, and reduce side effects, paving the way for more precise and effective treatments across a range of diseases.
Safely Scaling High Potency API Manufacturing
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.
Effect of Shelf Cooling Rate on the Nucleation Temperature of Ice Monitored Using Thermocouples and Wireless Temperature Sensors
Freezing conditions shape ice structure, mass transfer resistance, and drying efficiency. Data shows how cooling rate, vial size, and nucleation interact to optimize freeze-drying.
Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
The Strategic Value Of In-House Delumping For Homogeneous API Production
API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.